Background: A large, multicenter, 10-year observational study is comparing the long-term safety and effectiveness of Natrelle silicone breast implants versus saline implants or national norms. Methods: Women who underwent primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction were invited to participate. Enrolled subjects had completed surgery and received one implant or matching implants. Baseline demographics, health, lifestyle, and surgical characteristics are presented here for adult subjects who underwent primary reconstruction or revision-reconstruction. Results: Of 5637 subjects who underwent reconstruction surgery (86.7% primary reconstruction; 13.3% revision-reconstruction), 5407 received silicone implants and 230 received saline implants; 72.9% received bilateral implants. Silicone implants were used in 96.2% who underwent primary reconstruction and in 94.1% who underwent revision-reconstruction. Median age was about 3 years lower in those who underwent primary reconstruction versus revision-reconstruction. Most subjects were white nonsmokers and had attended college. Hispanic subjects were more likely to receive saline implants for primary reconstruction. Across groups, the most common characteristics by implant type or procedure included smooth-surface implants (90.8%), mastectomy scar site (69.7%), and partial (59.2%) or complete (33.9%) submuscular placement. Implant size was larger for revision-reconstruction versus primary reconstruction, and incision size was larger for silicone versus saline implants in subjects undergoing primary reconstruction. Conclusions: This study provides an unprecedented look at a large subject sample. The data offer surgeons an opportunity to make informed decisions regarding the most appropriate implant attributes and surgical approaches for women who desire breast implants for primary or revisionary breast reconstruction.
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